The Society for Nuclear Medicine and Molecular Imaging (SNMMI) is challenging the Centers for Medicare & Medicaid Services (CMS) to expand coverage for Amyloid PET. CMS had previously issued a national coverage determination (NCD) analysis for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. The letter with recommendations comes after continuous consultation with other stakeholders and response to requests for comment on the proposed decision. As of January 11, 2022, CMS had declared the therapy was to be covered. The decision would occur under coverage with evidence development (CED). SNNMI’s letter outlines several areas of opportunity for improvement when it comes to amyloid PET coverage.
NCD Coverage Flaws
With the current national coverage determination NCD 220.6.20, Medicare will only provide coverage for amyloid PET when it is administered in the setting of an approved clinical study under the Coverage with Evidence Development (CED) policy. According to SNNMI, “In the draft national coverage determination (NCD) on monoclonal antibodies, CMS proposes to provide the following coverage for amyloid PET:
For any CMS approved trials, or trials supported by the NIH, that include a beta amyloid positron emission tomography (PET) scan as part of the protocol, it has been determined that these trials also meet the CED requirements included in the Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease NCD (220.6.20), and one beta amyloid PET scan will be covered per patient, if the patient did not previously receive a beta amyloid PET scan.” The proposal is flawed because it incorrectly restricts access to the vital diagnostic data that is furnished by amyloid PET scans while creating “inefficiencies for study sponsors and patients.”
Another consequence is the potential for economic and emotional stress on patients who experience mild cognitive impairment and must devote time and resources to enrolling in a clinical trial prior to receiving a PET scan, “only to often find out after enrollment that they are not eligible to receive monoclonal antibodies because there is no beta-amyloid present in their brain.” Based on these flaws and more, the organization has advocated for a number of key improvements in a final NCD.
Opportunities for NCD Improvement
• Coverage existing prior to a patient deemed eligible for an approved study
The draft NCD dictates that amyloid PET coverage is restricted to the conditions where it is performed as part of the protocol for a study that adheres to CED requirements for coverage of monoclonal antibodies, essentially limiting coverage to patients enrolled in a clinical trial.
PET scans, they argue, provide critical information to assess whether the patient meets specific criteria, evaluating whether the patient actually has amyloid pathology that may align with Alzheimer’s disease (AD). The patient must be actively in the trial if study sponsors want to obtain data that assess if a patient is a candidate for therapy and ultimately a candidate for a clinical trial.
SNNMI notes that “This requirement is illogical, highly inefficient, and will create significant burdens for both trial sponsors and patients. Enrolling patients in a clinical trial, including obtaining the necessary informed consent agreement, requires substantial time and resources. It also requires educating the patient about the trial, the potential benefits of the study therapy, and the associated risks.”
The Amyloid PET allows the identification of any patients who will not receive benefit from aducanumab ahead of time while de-complicating the enrollment process for both patients and trial sponsors. The PET also makes patient care more efficient for those that don’t present with beta-amyloid since treating professionals and caregivers are free to concentrate on treatment methods that best match the patients’ needs.
Therefore, CMS should ultimately not restrict coverage purely to trial participants but must allow coverage of amyloid PET to ascertain whether the patient should be in the trial at all. According to SNMMI, “This will require that CMS finalize cover- age for one PET scan to all patients considered candidates for aducanumab. CMS could accomplish this by retiring the beta amyloid CED NCD or by establishing additional, non-CED coverage of beta amyloid PET as part of the monoclonal antibody NCD….we recommend that CMS retire NCD 220.6.20.”
With the letter providing strong reasoning for change, these are not all the arguments SNMMI has for coverage. Explore more regulatory, policy, and coding knowledge to master compliance and coding with our monthly Radiology Compliance Manager.